FDA.reportPublic FDA data

Methotrexate

Product NDC
50090-2345
11-digit product format
500902345
Labeler code
50090
Product ID
50090-2345_279705af-fac8-4afa-bd44-0980ef359a7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA081099
Marketing category
ANDA
Marketing start
1990-11-01
Marketing end
0000-00-00
Substance
METHOTREXATE SODIUM
Active strength
3 mg/1
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0Product name920250224
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3082de91-569a-4d57-b379-acbf37f1d5c3Product name120210312
f76135bc-a210-42d9-851b-1b73cbaccdb3Product name120200511
423544b2-e325-49ee-8910-4c5dfe41906fProduct name120181120
c9fd924b-0a8d-4d53-bf70-11070e24e4ddProduct name220181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359Product name120181120
eb454f54-2806-4c31-a08b-8dcb08261099Product name220181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27Product name120170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3Product name220160504
88514aea-9d58-4ed2-b135-9811fb14c8fbProduct name120141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2345-42020-01-31C16284748780-19d75b9d0-6250-f424-e053-dadaa90a57ceMethotrexate Tablets USP
50090-2345-92020-01-31C16284748780-19d75b9d0-6250-f424-e053-dadaa90a57ceMethotrexate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2345-4Methotrexate12 in 1 BOTTLETABLET127
50090-2345-9Methotrexate36 in 1 BOTTLETABLET367

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2345-9EA - Each50090-23452b4b2f86-f62b-4da5-83f4-9597412d83d012019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2345METHOTREXATE TABLET [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20190225_02862eb3-5508-4ea9-99fb-262551b6beeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSN02862eb3-5508-4ea9-99fb-262551b6beeb7
105585methotrexate 2.5 MG Oral TabletSCD02862eb3-5508-4ea9-99fb-262551b6beeb7
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSY02862eb3-5508-4ea9-99fb-262551b6beeb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2345-45009023450412 in 1 BOTTLEHistorical
50090-2345-95009023450936 in 1 BOTTLEHistorical